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  1. FDA Memoranda of Understanding

MOU 225-16-025

MOU 225-16-025

MEMORANDUM OF UNDERSTANDING
between THE FOOD AND DRUG ADMINISTRATION
and HEALTHEO360

I. PURPOSE AND GOALS

This Memorandum of Understanding ( “MOU”) establishes a framework for a cooperative public education program (“Program”) between two entities (each individually a “Party” and collectively the “Parties”): The Food and Drug Administration (FDA or Agency), Office of Health and Constituent Affairs (OHCA), Office of External Affairs (OEA) and Healtheo360, a website owned and operated by Healtheo360. The purpose of the Program is to provide and promote FDA information in the form of FDA health consumer information to consumers. This partnership offers high quality and timely content concerning public health and safety topics, including FDA alerts of emerging issues and product recalls.

II. BACKGROUND

FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. 301, et seq.). In fulfilling its responsibilities under the Act, FDA promotes and protects the public health by assuring the safety, efficacy, and security of drugs, biologics, veterinary products, and medical devices, as well as the safety and security of foods, dietary supplements, cosmetics, and radiological products. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. To accomplish its mission, FDA must stay abreast of the latest developments in medical research and communicate with stakeholders about complex scientific and public health issues. The collaborative development of research, education, and outreach partnerships with the Healtheo360 will greatly contribute to FDA’s mission.

Healtheo360 is a web-based "Caring Network" where patients living with chronic conditions, such as Diabetes, Cancer, Alzheimer's, and many others come to find support, encouragement, and information. The Healtheo360 community includes patients, their caregivers, family members and friends who come to share their personal healing stories so that others may find inspiration and motivation as they go through the journey of living with their condition. Members share their health related stories and learn from each other through discussion. Information may be shared as blogs or videos. Healtheo360’s services include Virtual Social Therapy (VST), peer counseling, support groups, educational publications and access to hundreds of videos. All services offered on the site are free of charge while raising awareness of all chronic disease conditions. Healtheo360 was developed to provide a safe online community to find support, encouragement, inspiration and a sense of belonging.

The Parties entered this MOU in mutual recognition of the need to empower consumers with health information they can apply in everyday life. This MOU meets the requirements set forth in FDA's policy statement on co-branding of Consumer health information, which is available online at https://www.fda.gov/forconsumers/default.htm. FDA and Healtheo360 recognize that this MOU is not intended, and may not be relied on, to create any right or benefit, substantive or procedural, enforceable by law by any party against the United States or against Healtheo360.

III. AUTHORITY

This MOU is authorized pursuant to FDA’s authority to provide information to the public under sections 705(b) and 1003(d)(2)(D) of the Food, Drug and Cosmetic Act (“the Act”) (21 USC 375(b), 393(d)(2)(D)).

IV. PROGRAM COMPONENTS AND ACTIVITIES

The components and activities of the Program are expected to increase FDA's capacity to disseminate FDA consumer information, which contain time-sensitive public health and safety information. The Program will include the following components:

FDA and Healtheo360 will:

  1. Determine and develop FDA topical educational, training and outreach programs for patients;
  2. Extend FDA's capacity to provide training and public health information for patients;
  3. Extend the reach of Consumer health information; and
  4. Provide consumers with better and timely information content concerning public health and safety topics, including emerging safety issues and product recalls.

V. To promote both the content and the collaborative relationship (as defined in this MOU), the Parties will routinely promote new consumer health information through social communities such as FaceBook and other social media platforms. FDA consumer information will have a weighted ranking for search purposes on Healtheo360 and search results on Healtheo360 will visually highlight FDA consumer information.

A. Consumer health information must be easily distinguishable from non-FDA content within the Program. Placement of FDA consumer health information within the Program should be clearly identified as such. Examples of clearly identifying FDA Consumer health information would be placing this information in a box and/or using a distinct color to distinguish it from non-FDA content, and/or otherwise clearly distinguishing the non-FDA content via an adequate disclaimer statement.

B. Printed and online pages containing consumer health information must be free of advertisements to avoid implying FDA's endorsement or support for a particular product, service, or website.

C. This MOU does not grant exclusivity to either Party. Neither Party is restricted from participating in similar initiatives with other public or private agencies, organizations, or individuals.

D. All activities within the scope of this MOU must comply with Section 508 of the Rehabilitation Act (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998 (see HHS policy on Section 508 compliance;  and Office of Management and Budget (OMB) policies for protecting private information.

E. FDA and Healtheo360 will cooperate in maintenance of each Party's trademarks and logos. The FDA will not permit use of its logo for marketing purposes other than to promote the Program. The use of FDA names or logos shall not imply any exclusive arrangement. FDA’s Consumer health information Staff must approve any use of FDA logos, in advance. All cobranded content (webpages, email alerts, and email newsletters) must be easily distinguishable from non-FDA content. Healtheo360 will use the FDA logo, disclaimers statements, and visual cues such as distinct coloring and boxes to distinguish cobranded content from non-FDA content. Healtheo360 will not use the FDA logo for marketing purposes other than to promote the co-branded FDA content.

F. Both Parties agree that information FDA provides to Healtheo360 shall be public domain material and be available through access channels such as RSS Feed. FDA shall have full rights to reuse the content for all FDA purposes, and the right to share with other collaborators or requestors.

G. Healtheo360 agrees to maintain current FDA consumer information within the site and Program. FDA consumer information must be removed from the Program in the following circumstances: (1) within 3 years of the date of its first publication; (2) upon termination of this MOU, if it terminates less than 3 years after the material is posted; (3) upon FDA's request in circumstances in which the information becomes outdated; or (4) as soon as commercially practicable but no longer than 72 hours after receipt of a written request from FDA to remove the material, regardless of reason. Healtheo360's failure to display current Consumer health information may result in the termination of this MOU.

H. This MOU does not and is not intended to transfer to either Party any rights in any technology or intellectual property.

VI. LINKS

FDA and Healtheo360 will provide inbound and outbound links to and from the Program and the FDA's Consumer health information webpage (www.fda.gov/consumer).

FDA will not provide Healtheo360 access to any document or information to the extent that providing such access would place the FDA in breach of the Trade Secrets Act, codified at 18 U.S.C. sec. 1905; the Privacy Act, codified at 5 U.S.C. sec. 552a; the Food, Drug, and Cosmetic Act, codified at 21 U.S.C. sec. 301, et seq (particularly 21 U.S.C. sec. 331(j); FDA regulations (21 Code of Federal Regulations (CFR); or any other Federal law or regulation.

VII. LIAISON OFFICERS

A. Food and Drug Administration
Steve Morin
Office of Health and Constituent Affairs
Office of External Affairs
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20903
301-796-0161
Steve.morin@fda.hhs.gov
 
Healtheo360
David S. Duplay
555 8th Avenue, Suite 1903
New York NY 10018
212-488-2130 Ext 2132
daved@healtheo360.com

Each Party shall appoint a representative who shall act as the liaisons between such Party and the other Party's representative. A Party may update its representative upon written notice to the other Party.

VIII.  TERM, TERMINATION, MODIFICATION, AND ASSESSMENT MECHANISMS

This MOU, when accepted by all Parties, will be effective for five years from the date of signature by the later Party to sign it. At the end of the first year, and annually thereafter, as long as the MOU remains in force, the Parties will evaluate the effectiveness of the MOU in meeting their goals and may amend the MOU, continue it as written, or dissolve the MOU by mutual consent. In addition, at any time, the Parties may modify the MOU by mutual written consent, and either Party may terminate the MOU at any time by means of a written notice of termination.

At least every two months, Healtheo360 will provide statistical information to FDA concerning the reach of the Program. This information will include metrics on the newsletter, alerts, and the number of users visiting the “Partnership Overview” page and each individual content item and pages contained therein, as well information concerning the reach of the content integrated with Healtheo360's mobile platform and social media channels. The Parties agree that Healtheo360 will provide information regarding usage to the FDA. This information will be jointly reviewed. The purpose of reviewing this information will be to evaluate the effectiveness of the collaboration and to make any necessary adjustments in approach, which may include termination of the partnership.

IX.  NO COMMITMENT OF FUNDS

All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds. Nothing in this MOU shall be construed to obligate either Party to make payments to the other.

X. LIMITATIONS ON LIABILITY

In no event will either Party be liable to the other under any theory of liability, however arising, for any costs of cover or for indirect, special, incidental, or consequential damages of any kind arising out of this MOU. The provisions of this Section IX shall survive termination, cancellation, or expiration of this MOU or any reason whatsoever.

XI. SIGNATURES OF RESPONSIBLE PARTIES

By signing this MOU, the responsible Parties agree to the terms and conditions of this MOU, and they further agree to adhere to FDA's policy statement on co-branding of FDA Updates.

Approved and Accepted for Healtheo360
David S. Duplay
Founder & CEO
November 15, 2016

Approved and Accepted for the U.S. Food and Drug Administration
Heidi Marchand
Assistant Commissioner for Health and Constituent Affairs
March 22, 2017